Voltaren Emulgel 2% Diclofenac Joint Pain Gel 100 g

Voltaren Emulgel 2% is a gel based on diclofenac diethylammonium .

Therapeutic indications

Voltaren Emulgel 2% is used in the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints (such as osteoarthritis and arthritis), muscles (such as contractures or injuries), tendons and ligaments (such as for example tendonitis).

Dosage and Posology

Voltaren Emulgel 2% should be used in the following doses:

• Adults over 18 years: apply Voltaren Emulgel 2 times a day on the area to be treated (preferably in the morning and in the evening), rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2- 4 g of Voltaren Emulgel 2% gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated with the gel. Warning: use only for short periods of treatment. The duration of treatment depends on the indication of use and the clinical response. The gel should not be used for more than 14 days without doctor's advice. Consult your doctor if symptoms persist or worsen after 7 days of treatment.
• Teenagers from 14 to 18 years: apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably in the morning and in the evening), rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2- 4 g of Voltaren Emulgel 2% gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated with the gel. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.
• Children below 14 years: There are insufficient data on efficacy and safety in children and adolescents below 14 years. Therefore, the use of Voltaren Emulgel 2% gel is contraindicated in children under 14 years of age.
• Elderly (over 65 years of age): The usual adult dosage may be used.

Overdose

The low systemic absorption of topical diclofenac makes an overdose very unlikely; however, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if Voltaren Emulgel 2% is inadvertently ingested (1 tube of 60g contains the equivalent of 1.2g of diclofenac sodium). In the event of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients;
• History of asthma attacks, hives or acute rhinitis following the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• During the third trimester of pregnancy;
• Use in children and adolescents under the age of 14 is contraindicated.

Side effects

Undesirable effects include mild and transient skin reactions at the application site. In very rare cases, allergic reactions can occur. Undesirable effects (Table 1) are listed below by organ, organ / system, and MedDRA frequency. Frequencies are defined as: very common (≥ 1/10) common (≥ 1/100 to <1/10); uncommon (≥ 1 / 1,000 to <1/100); rare (≥ 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000) not known (cannot be estimated from the available data).

- Infections and infestations

• Very rare: Rash with pustules.

- Disorders of the immune system

• Very rare: Hypersensitivity (including urticaria), angioedema.

- Respiratory, thoracic and mediastinal disorders

• Very rare: Asthma.

- Skin and subcutaneous tissue disorders

• Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus
• Rare: Bullous dermatitis.
• Very rare: Photosensitivity reaction, allergic reactions.

Pregnancy and breastfeeding

• Pregnancy

The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
The risk is believed to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality; in addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period.

During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases.
If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can 'progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.
Diclofenac is contraindicated during the third trimester of pregnancy.

• Feeding time

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, no effects on the infant are expected at therapeutic doses of the drug.
Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, the medicine should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for an extended period of time.

Special warnings

The possibility of systemic adverse events with the application of the medicinal product cannot be excluded if the preparation is used on large skin areas and for a prolonged period. The drug should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions.

It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested. Discontinue treatment if skin rash develops after application of the product. The product can be used with non-occlusive bandages, but must not be used with an occlusive bandage that does not allow air to pass.

The medicine contains propylene glycol. It can cause skin irritation. The drug contains butylhydroxytoluene. It can cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. This medicine does not require any special storage conditions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 g of Voltaren Emulgel 2% gel contain:

Active principle

2.32 g of diclofenac diethylammonium, equivalent to 2 g of diclofenac sodium.

Excipients

Butylhydroxytoluene, carbomers, cocoyl caprilocaprato, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleic alcohol, propylene glycol, pungent eucalyptus perfume, purified water.